A Study of Mericitabine in Combination With Boceprevir and Pegasys/Copegus in Patients With Chronic Hepatitis C

Completed · Phase 2 · Has a placebo group

Conditions studied: Hepatitis C, Chronic

In brief

This randomized, double-blind, multi-center, placebo-controlled, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) in combination with boceprevir and Pegasys/Copegus in patients with chronic hepatitis C infection. The anticipated time on study treatment is up to 48 weeks.

Key facts

Study ID

NCT01482403

Run by

Hoffmann-La Roche

People needed

58

Starts

2011-11-01

Expected to finish

2014-01-01

Last updated by the study team

2016-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients, >/=18 years of age
• Chronic hepatitis C infection for at least 6 months duration
• Hepatitis C genotype 1a or 1b
• Patients must have discontinued prior hepatitis C treatment at least 12 weeks prior to enrollment in this study
• Patient showed a previous null response to therapy as defined by < 2 log10 IU/mL decrease in viral titer after at least 12 weeks of treatment with PEG-IFN/RBV

You may not qualify if…

• Hepatitis C infection with a genotype other than genotype 1a or 1b
• Body mass index <18 or >/=36
• Hepatitis A, hepatitis B, or HIV infection
• Herbal remedies </=1 month prior to the first dose of study drug

Where it is running

• Study site — Littleton, Colorado, United States
• Study site — Chicago, Illinois, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Detroit, Michigan, United States
• Study site — Kansas City, Missouri, United States
• Study site — San Antonio, Texas, United States
• Study site — Chesapeake, Virginia, United States
• Study site — Calgary, Alberta, Canada
• Study site — Vancouver, British Columbia, Canada
• Study site — London, Ontario, Canada
• Study site — Créteil, France
• Study site — Nice, France
• Study site — Rennes, France
• Study site — Berlin, Germany
• Study site — Hamburg, Germany
• Study site — Hanover, Germany
• Study site — Naples, Campania, Italy
• Study site — Milan, Lombardy, Italy
• Study site — Florence, Tuscany, Italy
• Study site — Ponce, Puerto Rico
• Study site — Palma de Mallorca, Balearic Islands, Spain
• Study site — Santander, Cantabria, Spain
• Study site — Pontevedra, Pontevedra, Spain
• Study site — Valencia, Valencia, Spain

Full record on ClinicalTrials.gov

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